Kornimate/medical-research-clean huggingface dataset:
core stabalization and rebound therapy and cp

Conditions: Whole Body Vibration; Rebound Therapy; Balance; cp

Summary: the study aims to compare the effect of core stabalization and rebound therapy on balance in children with hemiplegic cerebral palsy

purpose: to compare the effect of core stabilization and rebound therapy on balance in children with hemiplegic cerebral palsy background: cerebral palsy is primarily a disorder of movement and posture hypotheses: there is no significant difference between core stabilization and rebound therapy on balance in children with hemiplegic cerebral palsy. research question: is there a significant difference between core stabilization and rebound therapy on balance in children with hemiplegic cerebral palsy?

Eligibility criteria:
inclusion criteria: * children diagnosed with spastic hemiplegic cp. * their chronological age ranged from 5 to 8 years, * able to follow verbal commands or instructions during testing procedures, * degree of spasticity in affected lower limbs ranged between1 to 1+ according to modified ashworth scale (mas), * they are able to understand and follow instructions given to them, exclusion criteria: * children who had significant visual or auditory problems that may interfere with testing, - ---- patients who had contractures or fixed deformities related to the joints of the lower limbs, ---- injection with botulinium toxin or any orthopaedic surgery in lower limbs 6m before study, * children who were suffering from cardiopulmonary problems or epilepsy.
enhanced recovery after surgery protocol on early mobilization after colorectal surgery

Conditions: Enhanced Recovery After Surgery; Anesthesia; Surgery-Complications; Colorectal; Early Mobilization

Summary: early mobilization is an important factor in increasing postoperative colorectal surgeries outcome. there are four components held by anesthesiologist in enhanced recovery after surgery protocol for colorectal surgery in our hospital: post operative nausea and vomiting (ponv) prophylaxis, intraoperative fluid management, intraoperative multimodal analgesia, and postoperative opioid-free pain management. although early mobilization affected by postoperative pain, vomiting and nausea, and fluid balance management, nonetheless, there is no clear evidence of how much each of these components will affect early mobilization.

early mobilization is an important factor in increasing postoperative colorectal surgeries outcome. there are four components held by anesthesiologist in eras protocol for colorectal surgery in our hospital: ponv prophylaxis, intraoperative fluid management, intraoperative multimodal analgesia, and postoperative opioid-free pain management. although early mobilization affected by postoperative pain, vomiting and nausea, and fluid balance management, nonetheless, there is no clear evidence of how much each of these components will affect early mobilization. this study was a retrospective cohort study by collecting secondary data from patients underwent elective colorectal surgery in our hospital from january 2020 to december 2022. the outcomes assessed were early mobilization rate and factors affecting it (ponv prophylaxis, intraoperative fluid management, intraoperative multimodal analgesia, and postoperative opioid-free pain management).

Eligibility criteria:
inclusion criteria * patient underwent colorectal surgery in cipto mangunkusumo hospital from 2020 to 2022 * age 18-60 years old * american society of anesthesiologist (asa) physical status 1, 2, and 3 exclusion criteria * patients who were not intubated on postoperative period * patients who had physical limitation during preoperative mobility test

Keywords: early mobilization enhanced recovery after surgery ponv prophylaxis fluid management pain management
early cessation of sedation and ttm in patients with a favourable eeg after cardiac arrest

Conditions: Hypoxia-Ischemia, Brain; Heart Arrest

Summary: the objective of this study is to estimate the feasibility and safety of early weaning from icu treatment in patients after cardiac arrest and an early (\< 12 h) favourable eeg pattern (indicating no or mild postanoxic encephalopathy).

comatose patients after cardiac arrest are treated on intensive care units with sedative medication, targeted temperature management (ttm), mechanical ventilation, and hemodynamic support. despite substantial variation in the severity of the encephalopathy and even lack of unequivocal evidence of efficacy of sedation and ttm, all patients receive standard treatment. the severity of the postanoxic encephalopathy can reliably be assessed with the electroencephalogram (eeg). a continuous eeg pattern within the first 12 hours after cardiac arrest ("favorable eeg") is strongly associated with a good neurological outcome and reflects a very mild or transient encephalopathy. the investigators hypothesize that this subgroup of patients, with a favorable eeg will not benefit from prolonged sedation and ttm. the objective of this study is to estimate the feasibility and safety of early weaning from icu treatment in patients after cardiac arrest and an early (\< 12 h) favourable eeg pattern. the study design is a cluster randomized crossover design with two treatment arms. the intervention contrast will be early cessation of sedation and ttm, with subsequent weaning from mechanical ventilation if appropriate (intervention group) vs. standard care, including sedation and ttm for at least 24-48 hours (control group). the investigators will include forty adult patients admitted to the icu with postanoxic encephalopathy after cardiac arrest and an early (\<12 hours) favorable eeg pattern.

Eligibility criteria:
inclusion criteria: * patients after cardiac arrest admitted to the icu for treatment with sedation, ttm and mechanical ventilation. * age 18 years or older. * continuous eeg measurement started within 12 hours after cardiac arrest. * favourable eeg pattern within 12 hours after arrest, defined as a continuous background pattern (nvn, 2019; ruijter et al., 2019). * possibility to stop sedative treatment within three hours after identification of a favourable eeg pattern. * written informed consent (deferred). exclusion criteria: * a known history of another medical condition with limited life expectancy (\<6 months). * any progressive brain illness, such as a brain tumour or neurodegenerative disease. * pre-admission glasgow outcome scale extended score of 4 or lower. * reason other than neurological condition to continue sedation and/or ventilation. * follow-up impossible due to logistic reasons.

Keywords: eeg targeted temperature management (ttm)
effect of phosphate binders on fgf-23 with concurrent calcitriol

Conditions: Chronic Kidney Disease Stage 3

Summary: chronic kidney disease (ckd) is an established risk factor for cardiovascular morbidity and mortality, as shown by common manifestations of left ventricular hypertrophy (lvh) and arterial calcifications in ckd patients. fibroblast growth factor-23(fgf-23) is a recently identified phosphaturic hormone that has been reported to be associated with the development of secondary hyperparathyroidism, cardiovascular morbidity, mortality, ckd progression. while vitamin d is the mainstay therapy in ckd mineral bone disease (ckd-mbd), increased fgf-23 levels have been reported with vitamin d administration. the purpose of this study was to investigate the effect of calcium carbonate when used in conjunction with calcitriol on fgf-23.


Eligibility criteria:
inclusion criteria: * adults of 18\~70 years of age * ckd stage 3 patients (gfr: 30-60ml/min/1.73m2) * patients who've given consent to the trial exclusion criteria: * known allergy to vitamin d or calcium carbonate * administration of vitamin d analogue or phosphate binders 3 months prior to study entry * history of hypercalcemia (corrected serum calcium \> 10.5 mg/dl) or hypophosphatemia (serum phosphate \< 2.5 mg/dl) 3 months prior to study entry * patients with bone pathologies or diseases requiring vitamin d therapy that is unrelated to ckd-mbd * administration of concurrent medication , diseases, or history of surgeries that may affect bone-mineral metabolism or alter bone status * patients diagnosed with rapidly progressive glomerulonephritis(rpgn) or those in need of renal replacement therapy * patients with obstructive bowel diseases, or severe gastrointestinal diseases * patients with less than 2 years of life expectancy(ex. malignancy diseases)

Keywords: fgf-23 calcitriol calcium carbonate ckd stage 3
china made sirolimus eluting stent for intermediate lesion

Conditions: Coronary Artery Disease

Summary: sirolimus-eluting stent (ses) has been proven to improve outcomes in patients with significant coronary artery diseae(\> 70% lumen diameter narrowing). but, acute coronary syndrome may occur in those with intermediate lesions(50%-70% lumen diameter narrowing), and the effect of ses in these patients remains unclear. here the investigators hypothesize that application of china-made ses may improve the clinical outcomes in these setting.


Eligibility criteria:
inclusion criteria: * age 18-80 years old * both gender * native coronary lesion * narrowing 50-70% * vessel size 2.5-4.0 in diameter exclusion criteria: * without informed consent, * st elevation myocardial infarction within 7 days, * left main lesion, * by-pass graft, * restenosis * abnormal liver function before randomization, * active hepatitis or muscular disease, * impaired renal function with serum creatinine level \> 3mg/dl , * impaired left ventricular function with lvef \< 30%, * participate in other studies.
long-term safety study of alogliptin in participants with type 2 diabetes in japan

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study was to evaluate the long-term safety and efficacy of syr-322, once daily (qd), to an α-glucosidase inhibitor, three times daily (tid), administered for 40 consecutive weeks in participants who completed a phase 2 dose-ranging study.

both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. takeda is developing syr-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. alogliptin is an inhibitor of the dipeptidyl peptidase iv (dpp-iv) enzyme. dpp-iv is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. it is expected that inhibition of dpp-iv will improve glycemic control in patients with type 2 diabetes. to evaluate the long-term safety and efficacy of alogliptin, this extension study was administered for 40 consecutive weeks (52 weeks from the start of treatment in the phase 2 dose-ranging study) to participants who had completed the phase 2 dose-ranging study syr-322/cct-001 (nct01263470).

Eligibility criteria:
inclusion criteria: * had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at week 12). exclusion criteria: * had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at week 8 of treatment in the phase 2 dose-ranging study). * had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dl or more at week 8 of treatment in the phase 2 dose-ranging study).

Keywords: diabetes mellitus - type 2 diabetes mellitus drug therapy
a study of bms-986315 and nivolumab in combination with chemotherapy in participants with first-line stage iv or recurrent non-small cell lung cancer (nsclc)

Conditions: NSCLC

Summary: the purpose of this study is to evaluate the efficacy and safety of bms-986315 plus nivolumab in combination with platinum-based doublet chemotherapy (pdct) versus nivolumab in combination with pdct in the first-line treatment of stage iv or recurrent non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * participants must have nsclc with stage iv or recurrent disease following multimodal therapy for locally advanced disease. * study treatment must be first-line therapy for stage iv or recurrent disease. * participants in all parts of the study must have: * measurable disease per response evaluation criteria in solid tumors version 1.1. (recist v1.1) * an eastern cooperative oncology group (ecog) performance status of 0 or 1 * a life expectancy of at least 3 months at the time of first dose exclusion criteria: * untreated symptomatic central nervous system metastases * participants with epidermal growth factor receptor (egfr)/alk receptor tyrosine kinase (alk)/ros proto-oncogene 1 (ros1)/neurotrophic tyrosine receptor kinase (ntrk)/met proto-oncogene (met)/b-raf proto-oncogene (braf)/ret proto-oncogene (ret) mutations amenable to targeted therapies * participants with any known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results note: other protocol-defined inclusion/exclusion criteria apply.

Keywords: pharmacokinetics bms-986315 nivolumab platinum doublet chemotherapy nsclc lung cancer
basic assessment of safety and minimally invasive stimulation via injectrode

Conditions: Chronic Lower Limb Pain

Summary: the objectives of this non-significant risk (nsr) study are to evaluate the safety of the short term placement of the basmati injectrode for up to 28 days and the efficacy of conducting electrical current to stimulate subcutaneous nerves on the explant date just prior to explant.

this was a prospective, single-center, single-arm, non-randomized study design. a sample of 10 study participants were enrolled into the study, and provided with the placement of a basmati injectrode insert with a maximal placement duration of up to 28 days. subjects who were selected to participate in the trial were healthy volunteers adults with ages 18 years and older without any preexisting condition indicated for treatment. each subject was followed during the trial period of approximately 45+/-2 days.

Eligibility criteria:
inclusion criteria: * sign a valid, institutional review board (irb)-approved informed consent form (icf) and understand the study requirements. * be 18 years of age or older when written informed consent is obtained. * be in good physical and mental health as assessed by a general practitioner. * be able to tolerate electrical stimulation (tens). * be willing and able to understand and comply with all study-related procedures during the course of the study. exclusion criteria: * have a cognitive impairment or exhibit any characteristic that would limit the study candidate's ability to completely understand and sign a valid, irb-approved informed consent form. * have a positive pregnancy test (conducted during enrollment). * have a positive allergic reactivity to gold skin test (conducted during enrollment). * show symptoms indicative for covid19 as assessed during enrollment. * have a skin condition at the planned surgical location. * have a blood coagulation disorder or other indication with the potential to impact the study biocompatibility data in unpredictable ways. * have a medical condition that is a contraindication for minimally invasive surgery. * be implanted with a cardiac defibrillator or pump. * have a history of cardiac arrhythmia with hemodynamic instability * be implanted with a neurostimulator. * have any active electrical implant of any other kind. * have metal implants (particularly in hip). * have active infection. * have allodynia. * take regular use of antiplatelet medications (e.g. aspirin, ticlopidine (ticlid), clopidogrel (plavix), tirofiban (aggrastat) or eptifibatide (integrilin)). * have untreated drug habituation or dependence. * have uncontrolled seizures (averaging \> 2 seizures per month). * currently require, or be likely to require, diathermy and/or mri during study duration. * have a history of adverse reactions to local anesthetics (e.g. lidocaine).

Keywords: electrode injectable electrode injectrode medical device safety
phase 1b/2 study to evaluate abt-101 in solid tumor and nsclc patients

Conditions: Advanced Solid Tumor; Non Small Cell Lung Cancer; HER2 Mutations

Summary: a phase 1b/2, open-label, multicenter study to determine the recommended phase 2 (rp2d) of abt-101in solid tumor and to explore antitumor activities of abt-101 in patients with her 2 mutated non-small cell lung cancer (nsclc)

this study will be conducted in two parts: part 1: dose- escalation, phase 1b, is designed to determine the rp2d. patients with solid tumor will be enrolled into a dose finding study scheme with the assessment of dose-limiting toxicities (dlts). dlt assessment will be conducted during treatment cycle 1 part 2: dose- expansion, phase 2, will evaluate the safety and efficacy of abt-101 at the dosage and dosing regime determined in phase 1b. phase 2 will enroll nsclc patients with her2 mutations study participation for all patients includes screening period, treatment period and safety/ follow-up period. patient will received study treatment until progressive disease or any other discontinuation or withdrawal criterion is met

Eligibility criteria:
inclusion criteria: * male or female aged ≥ 20 years or adult age as per local regulations, at time of informed consent * histologically or cytologically confirmed advanced solid tumor (part 1) or nsclc with her2 mutations as determined by the central result (part 2) * for patients in part 2 only: patients has measurable disease per recist 1.1 criteria * eastern cooperative oncology group (ecog) performance status of 0 or 1 (part 1), 0 to 2 (part 2) * appropriate candidate for experimental therapy * adequate organ function exclusion criteria: * known active or untreated central nervous system (cns) metastases and/or carcinomatous meningitis * for patients in part 2 only: previously treated with egfr or her2 tkis. * serious acute or chronic infections * received a live-virus vaccination * received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose. * not recovered from prior- treatment toxicities to grade ≤1 * major surgery within 28 days prior to the study treatment * concurrent malignancy within 2 years prior to first dose * history or presence of clinically relevant cardiovascular abnormalities. qtcf ≥ 470 ms * significant gastrointestinal disorder(s) that could interfere with absorption of abt101 * known to have a history of alcoholism or drug abuse

Keywords: abt-101 nsclc her2 mutations
[18f]fluoro-peg-folate pet/ct imaging in epithelial ovarian cancer

Conditions: Epithelial Ovarian Cancer

Summary: the pre-operative assessment of intra-abdominal tumor load in patients with epithelial ovarian cancer (eoc) remains unreliable with standard imaging modalities. the use of tumor targeted imaging, such as folate receptor (fr)-targeted positron emission tomography (pet) imaging could aid in the preoperative assessment of metastatic tumor load. this study aims to evaluate the safety and tolerability, and pharmacokinetics of the \[18f\]fluoro-peg-folate pet tracer and to assess the sensitivity and specificity of a \[18f\]fluoro-peg-folate pet/ct scan for the preoperative detection of intra-abdominal metastatic lesions in patients with advanced stage epithelial ovarian cancer.


Eligibility criteria:
inclusion criteria: patients with radiologically figo stage iiib/iiic eoc based on the conventional ct scan who are: * scheduled to undergo primary cytoreductive surgery and 1. in whom eoc is histologically proven, or 2. in whom eoc is cytologically suspected and a serum ca125/cea ratio \> 25 is found or * treated with neoadjuvant chemotherapy (nact) and are scheduled to undergo interval cytoreductive surgery and 1. in whom eoc is histologically proven, or 2. in whom eoc is cytologically suspected and a serum ca125/cea ratio \> 25 was found before nact 3. and with radiologically figo stage iiib/iiic eoc based on the response evaluation ct scan after nact exclusion criteria: 1. women younger than 30 years of age (in accordance with the guidelines of the netherlands commission on radiation dosimetry \[23\], as the total radiation dose will be 7.2 msv) 2. patients who previously underwent primary laparotomy and in whom complete or optimal cytoreduction was not considered feasible. 3. contraindication for pet (pregnancy, lactating or severe claustrophobia) 4. thrombocytopenia (platelet count \ 2 5. impaired renal function (defined as egfr \< 50 ml/1.73 m2) 6. impaired liver function (alt, ast or total bilirubin \> 3x upper limit of normal) 7. clinically significant abnormalities on ecg and/or clinically laboratory test 8. inability to tolerate lying supine for the duration of a pet/ct examination (\~110 minutes) 9. patients with concomitant malignancy (except basal cell carcinoma of the skin) or any condition that in the opinion of the investigators could potentially jeopardize the health status of the patient 10. patients not able to comply with the study procedures 11. patients who did not give informed consent
research on the combined-modality treatment model of bladder preservation in muscular invasive bladder cancer

Conditions: Bladder Cancer

Summary: this research aims to explore the therapeutic effect of neoadjuvant chemotherapy in muscular invasive bladder cancer of t2-4an0m0, and the survival effect of combined-modality treatment model，then to clarify the probability of bladder preservation, corresponding cancer specific survival, and the quality of life.


Eligibility criteria:
inclusion criteria: 1. bladder urothelium carcinoma 2. ct2-4an0m0 3. life expectancy≥1 year 4. ecog ps 0-1 5. have no previously received radiotherapy or chemotherapy 6. have no major organ dysfunction 7. have been provided informed written consent exclusion criteria: 1. extensive carcinoma in situ or ureter invaded 2. distant metastasis at primary diagnosis or lymphatic metastasis according to clinical diagnosis 3. have severe major organ dysfunction 4. cannot finish treatments because of other severe diseases or life expectance≤6 months 5. exist other malignant tumors 6. have severe coagulation disorders 7. no other trails participated in 4 weeks